Tannin Specific Natural Extract for COVID-19 Infection

COVID-19 Clinical Trial

— TanCOVID  

Official title:

Efficacy of Tannin Specific Natural Extract for Coronavirus Disease (COVID-19): Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04403646
• Other study ID #: HCJSM-20-005
• Status: Terminated
• Phase: N/A
• Start date: June 12, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: December 2020
• Source: Hospital de Clinicas José de San Martín
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is an urgent need to evaluate interventions that could be effective against the infection with SARS-CoV 2. Tannins based wood extracts are an inexpensive and safe product with protective effect in both bacterial and viral infections likely due to its anti- inflammatory, anti-oxidative effects and their modulation of the intestinal microbiota. This randomized controlled trial seeks to evaluate the efficacy of the tannins based dietary supplement ARBOX in positive COVID-19 patients.

Description:

The epidemic of 2019 novel coronavirus (causing the disease Covid-19) has expanded from Wuhan throughout China and is being exported to a growing number of countries, some of which have seen onward transmission. COVID-19 caused clusters of severe respiratory illness and was associated with 2% mortality. There is currently no vaccine and no specific antiviral treatment recommended for COVID-19. About 20% of the patients were severe and the mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients. Therefore, it is urgent to find a safe and effective therapeutic approach to COVID-19.

Tannins have been shown to have antioxidant, anti-inflammatory, antimicrobial properties and a regulatory effect on the gastrointestinal metabolism.

The investigators will realize a prospective, double-blind, randomized trial to assess the effect of treatment with a dietary supplement (ARBOX), a molecular complex of quebracho and chestnut tannins extract and Vit B12, compared with placebo. 140 COVID-19 patients will be recruited in a single center in Buenos Aires Argentina. 70 patients will receive conventional treatment plus ARBOX (treated group) and 70 patients will receive conventional treatment plus placebo (control group). The effects will be evaluated during the 28 days follow up. The primary end point will be the time of discharge from the hospital. A panel of 27 cytokines level, intestinal microbiota composition and its metabolites will be assessed at day 1 and 14.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 124
• Est. completion date: November 1, 2020
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years of age hospitalized in the general hospitalization room, who meet the definition of "Confirmed case COVID-19" (https://www.argentina.gob.ar/salud/coronavirus-COVID-19/definicion -of-case)

Exclusion Criteria:

• Pregnancy

• Lactancy

• Hypersensitivity to polyphenols

• Patients unable to receive oral medication (severe cognitive impairment, assisted ventilation, impaired state of consciousness)

• Lack of consent

• Participation in any other interventional clinical trial

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• Infection
• SARS-CoV 2
• Severe Acute Respiratory Syndrome

Intervention

Dietary Supplement:
• ARBOX
dry extract of polyphenols (tannins) form quebracho and chestnut 240 mg, B12 vitamin 0.72 µg

Other:
• PLACEBO
Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for ARBOX

Locations

Country	Name	City	State
Argentina	Hospital de Clinicas	Buenos Aires

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas José de San Martín	SILVATEAM

Country where clinical trial is conducted

Argentina, 

References & Publications (3)

Theisen LL, Erdelmeier CA, Spoden GA, Boukhallouk F, Sausy A, Florin L, Muller CP. Tannins from Hamamelis virginiana bark extract: characterization and improvement of the antiviral efficacy against influenza A virus and human papillomavirus. PLoS One. 2014 Jan 31;9(1):e88062. doi: 10.1371/journal.pone.0088062. eCollection 2014. — View Citation

Ueda K, Kawabata R, Irie T, Nakai Y, Tohya Y, Sakaguchi T. Inactivation of pathogenic viruses by plant-derived tannins: strong effects of extracts from persimmon (Diospyros kaki) on a broad range of viruses. PLoS One. 2013;8(1):e55343. doi: 10.1371/journal.pone.0055343. Epub 2013 Jan 25. — View Citation

Zhang L, Cheng YX, Liu AL, Wang HD, Wang YL, Du GH. Antioxidant, anti-inflammatory and anti-influenza properties of components from Chaenomeles speciosa. Molecules. 2010 Nov 22;15(11):8507-17. doi: 10.3390/molecules15118507. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to hospital discharge	defined as the time from first dose of polyphenol extract to hospital discharge	Throughout the Study (Day 0 to Day 28)
Secondary	28-day all-cause mortality	proportion	Throughout the Study (Day 0 to Day 28)
Secondary	invasive ventilation on day 28	proportion	Throughout the Study (Day 0 to Day 28)
Secondary	Difference in Pro and antiinflammatory citoquine levels	mean difference	day 1-14
Secondary	Difference in fecal intestinal microbiota composition		day 1-14
Secondary	Negativization of COVID-PCR at day 14	proportion	day 14